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OpenTrials
Completed

NCT Number: NCT05438433

Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement

Are there differences in outcome of mitral valve replacement with preservation of mitral apparatus among rheumatic and/or ischemic mitral lesions?.

Mitral valve replacement with preservation of leaflets, and added coronary artery-bypass surgery, when indicated, is it a feasible and reproducible procedure?.

The study was designed to compare outcome after prosthetic mitral replacement with preservation of mitral apparatus for rheumatic valve disease with outcome of replacement for ischemic myocardium and mitral valve disease, The outcomes will be guided by clinical assessment. and echo-cardiograph.

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Key information

Conditions

Diseases of Mitral Valves Abnormality of Mitral Valve Annulus (Disorder) Ischemia Mitral Valve Replacement Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University, Ismailia, Egypt

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About this study

Objectives: The aim is to compare outcome of modified preservation of mitral valve apparatus during prosthetic mitral replacement for rheumatic versus myocardial ischemia &mitral valve disease.

Methods ;This prospective cross-sectional comparative study will include 50 patients with isolated rheumatic mitral valve disease (group A) and 50 patients with mitral disease and myocardial ischemia (group B), surgery is expected to be performed between 2017 and 2020 at one center. All patients will have modified preservation of mitral apparatus during prosthetic mitral replacement. Additionally, group B patients will have bypass grafts to left anterior descending and/or posterior descending / right coronary artery. Data will be collected and analyzed.

The Institutional Review Board (IRB), Ethics Committee (EC)-approval and consent of each patient were obtained.

Criteria for inclusion of patients and exclusion of others were determined according to the guide lines.

Statistical analysis::

Qualitative variables and their association among both groups were studied by applying Chi-square test and Fisher Exact test. Quantitative variables among both groups were compared by applying independent samples t-test. P < 0.05 values mean statistically-significant results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

:

Mitral stenosis (MS)

  • symptoms are severely limiting and cannot be managed with diuresis and heart rate control.

Mitral regurgitation(MR):

  • acute severe MR require surgical correction for hemo-dynamics and relief of symptoms .

Chronic primary mitral regurgitation:

  • rheumatic heart disease: replacement before irreversible changes occur can be curative.

Mixed Mitral Stenosis and Mitral Regurgitation:

  • If beta blockers and diuretics do not relieve symptoms, replacement should be performed only in patients who have severe limiting symptoms.
  • Myocardial ischemia associating or complicated with miral valve disease.

Exclusion criteria

  • Patients showing good response to medical therapy, and Cases complicated by:
  • ineffective endocarditis,
  • previous myocardial re-vascularization
  • ischemic ventricular septal defect,
  • left ventricular aneurysm,
  • Ruptured papillary muscles of mitral apparatus.

Treatment and study plan

St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets

Device

St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts

Other names: St.Jude bi leaflet prosthesis to replace diseased valve with preservation of leaflets with Myocardial re-vascularization, St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease

Primary outcomes

  1. Smoking index

    Time frame: One week before surgery(or during first clinical visit) .

    Number of Packs every day X number of years of smoking= Pack.year,

  2. Age and gender for each participant

    Time frame: One week before surgery .

    Males above 40 years and Females above 45 years need pre-operative coronary angio-graph

  3. For each participant: pathological:type of mitral valve lesion

    Time frame: Seven days before surgery .

    severe stenosis with mitral area < 1 cm square, severe regurgitation, or mixed lesions

  4. For each participant: etiological :type of mitral valve lesion

    Time frame: Seven days before surgery .

    Rheumatic: distorted thickened leaflets,thickened fibrosed chordae

  5. For each participant: etiological :type of mitral valve lesion

    Time frame: Seven days before surgery- echo-cardiograph.

    Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence

  6. For each participant:, assessing sub-valvular apparatus

    Time frame: One week before surgery. with Echo-cardiograph.

    Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.

  7. Abascal echo-cardiographic mitral valve score (Wilkins score)

    Time frame: One week before surgery.with Echo-cardiograph

    :if score is 8 or less it is good for balloon valvo-plasty, if > 8 surgery is recommended ( leaflet mobility, thickness and calcification. Fourthly, sub-valvular thickening., higher scores = more deterioration

  8. left ventricular wall motion abnormality

    Time frame: one week before surgery - with an echo-cardiograph

    hypokinesia, Akinesia, Dyskinesia of certain segment(s)

  9. Number of participants with Signs of left ventricular dysfunction

    Time frame: seven days before surgery echo-cardiograph examination

    low ejection fraction <52%, low stroke volume< 70 ml, low cardiac output <5 litres per minute

  10. Number of participants with pre-operative coronary artery disease

    Time frame: seven days before surgery, coronary angio-graph

    Expected on clinical bases and .proved by Echo-cardiograph-findings

  11. Number of participants with pre-operative ischemic complications

    Time frame: seven days before surgery echo-cardiograph examination

    left ventricular thrombi, septal and left ventricular wall thickness in mm .

  12. Assessment of any evolving new prosthetic valve dysfunction

    Time frame: intra-operative trans-esophageal echo-cardiograph examination

    Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus

  13. Change in post-operative left ventricular functions

    Time frame: 5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph

    : Low Fractional Shortening < 28% , Ejection fraction < 40%,, increased left ventricular dimensions and volume

  14. Change of Prosthetic mitral valve functions

    Time frame: Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph

    Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus

Secondary outcomes

  1. changes on Clinical examination

    Time frame: Monthly up to 12 months after surgery)

    local and general Examination,: a new murmur, evolving heart failure

  2. Changes in Results of Prothrombin time, concentration and.International normalized ratio

    Time frame: .Monthly through study completion up to 12 months.

    Adjust dose of oral anticoagulant.( between double and half to three times the control) Dose usually ranges between 1 and 11 mg warfarin tablet daily.

  3. Mortality and Morbidity

    Time frame: Monthly through study completion up to 12 months.

    cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Collaborators

  • National Research Centre, Egypt

Registry information

Official study title

Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement

Acronym: EarlyOutcome

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jun 30, 2022
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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